Validity study of oscillometric blood pressure measurement devices using an oscillometric waveform simulator
Author
Newell, Sara Rose
Term
4. term
Education
Publication year
2013
Submitted on
2013-06-03
Pages
97
Abstract
Blodtryk er en af de mest almindelige målinger i sundhedsvæsenet. Forbrugerapparater sælges i stor skala—alene i Tyskland købes ca. 1,2 millioner blodtryksmålere årligt—men mange apparater på EU‑markedet er efter sigende ikke formelt valideret for nøjagtighed. Formålet med dette studie var at sammenligne eksterne og interne manchetter ved brug af en oscillometrisk bølgeformsimulator, at undersøge nøjagtighed og variation inden for to modeller af blodtryksmålere, og at vurdere om en simulator kan bruges ved indkøb af apparater før klinisk implementering. Vi testede to modeller (10 enheder per model) med en oscillometrisk bølgeformsimulator—et udstyr, der efterligner de trykpulser i en arm, som automatiske blodtryksmålere analyserer. Simulatoren genererede 8 fysiologiske bølgeformer. Nøjagtighed blev vurderet mod en acceptgrænse på ±3 mmHg (millimeter kviksølv). Forskelle mellem opsætninger med ekstern og intern manchet holdt sig inden for ±3 mmHg, men mange apparater kunne ikke indgå i testen med simulatorens interne manchet. Ingen af modellerne leverede gyldige målinger inden for ±3 mmHg for alle 8 simulationer. Fejl spændte fra −3 til +4 mmHg for Model 1 og fra −8 til +6 mmHg for Model 2. Enheder inden for samme model adskilte sig også signifikant. Resultaterne peger på, at flere forhold kan påvirke nøjagtigheden, herunder brugen af forskellige, proprietære algoritmer i simulator og apparater samt variation på grund af manglende kalibrering af tryktransducere. Der er behov for mere forskning i den oscillometriske metode og bølgeformer for at kunne udvikle mere nøjagtige blodtryksmålere og bedre simulatorer.
Blood pressure is one of the most common measurements in healthcare. Consumer monitors are widely sold—about 1.2 million are bought each year in Germany alone—but many devices on the EU market are reportedly not formally validated for accuracy. This study aimed to compare external and internal cuffs when using an oscillometric waveform simulator, assess the accuracy and within‑model variation of two blood pressure monitor models, and explore whether a simulator can support device selection before clinical use. We tested two models (10 units per model) with an oscillometric waveform simulator—a device that mimics the arm pressure pulses analyzed by automatic monitors. The simulator produced 8 physiological waveforms. Accuracy was judged against an acceptance limit of ±3 mmHg (millimetres of mercury). Differences between external and internal cuff setups stayed within ±3 mmHg, but many devices could not be included when the simulator’s internal cuff was used. Neither model achieved valid readings within ±3 mmHg for all 8 simulations. Errors ranged from −3 to +4 mmHg for Model 1 and from −8 to +6 mmHg for Model 2. Units of the same model also differed significantly. These findings suggest several factors may affect accuracy, including differing proprietary algorithms in simulators and monitors and variability from uncalibrated pressure transducers. Further research on the oscillometric method and waveforms is needed to inform the design of more accurate monitors and better simulators.
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